Abstract
BackgroundWomen with pathogenic BRCA germline mutations have an increased risk for breast and ovarian cancer that seems to be modified by life-style factors. Though, randomized trials investigating the impact of lifestyle interventions on cancer prevention and prognosis in BRCA carriers are still missing.MethodsWe implemented a multicenter, prospective randomized controlled trial in BRCA1/2 patients, comparing a lifestyle intervention group (IG) with a control group (CG) with the primary aim to prove feasibility. Intervention comprised a structured, individualized endurance training alongside nutrition education based on the Mediterranean diet (MD) for 3 months, plus monthly group training and regular telephone contact during the subsequent 9 months. The CG attended one session on healthy nutrition and the benefits of physical activity. Primary endpoints were feasibility, acceptance and satisfaction over 12 months. Furthermore, effects on physical fitness, diet profile, body mass index (BMI), quality of life and perceived stress were investigated.ResultsSixty-eight participants (mean age 41, mean BMI 23.2 kg/m2) were enrolled, of whom 55 (81%, 26 IG, 29 CG) completed 12 months. 73% (n = 26) participated in at least 70% of all intervention sessions. Predictors for drop-outs (19%; n = 13) or non-adherence (27%; n = 7) were not found. 73% rated the program highly and 80% would participate again. Severe adverse events did not occur. Positive effects in the IG compared to the CG were observed for secondary endpoints: BMI, MD eating pattern and stress levels.ConclusionsThis lifestyle intervention was feasible, safe and well accepted. Positive results on eating habits, physical fitness and stress levels warrant a larger randomized trial.Trial registrationThe study has been retrospectively registered at ClinicalTrials.gov (reference: NCT02087592) on March 12, 2014. The first patient was included on February 24, 2014.
Highlights
Women with pathogenic BRCA germline mutations have an increased risk for breast and ovarian cancer that seems to be modified by life-style factors
Baseline characteristics A total of 68 women with pathogenic BRCA1 or BRCA2 mutations were included in the study. 46 out of 68 (68%) participating females had been diagnosed with cancer before inclusion, 43 suffering from breast cancer, two had ovarian cancer and one with both ovarian and breast cancer
The intervention indicated that relevant beneficial effects on body weight, stress levels and changes in nutritional behavior towards a Mediterranean-eating pattern can be achieved
Summary
Women with pathogenic BRCA germline mutations have an increased risk for breast and ovarian cancer that seems to be modified by life-style factors. Women with BRCA germline mutations have considerably increased lifetime risks for breast (55–60%) and ovarian (16–59%) cancer [1, 2]. Regular physical activity has a tremendous impact on breast cancer incidence, and mortality. The breast cancer risk of pre and postmenopausal women can be reduced by regular training on average by 25% [7]. The engagement in regular physical training reduces the risks of recurrence and mortality in women with breast cancer by 50% [8] and leads to further advantages like gain in quality of life, increased fitness and improved tolerance of chemotherapy [9]
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